Neurosurgery Patient Outcomes in Treating Spinal Disorders (Neuropoint SD)

This study has been completed.
Sponsor:
Collaborator:
American Association of Neurological Surgeons
Information provided by:
Greenwich Hospital
ClinicalTrials.gov Identifier:
NCT01220921
First received: October 13, 2010
Last updated: December 3, 2015
Last verified: December 2015
  Purpose
The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .

Condition Intervention Phase
Symptomatic Lumbar Disc Herniation
Symptomatic Grade I Lumbar Spondylolisthesis
Procedure: Lumbar Discectomy
Procedure: Single-level lumbar fusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Neurosurgery Patient Outcomes in Treating Spinal Disorders

Resource links provided by NLM:


Further study details as provided by Greenwich Hospital:

Primary Outcome Measures:
  • SF-36 version 1 [ Time Frame: 1-Year ] [ Designated as safety issue: No ]
    Health-realted quality of life outcome measure

  • Site and Physician Compliance [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments


Secondary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Validated lumbar spine disease-specific outcomes instrument

  • Visual Analog Pain Score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Patient-reported pain intensity scored 1-10

  • Return to Work [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Return to work assessments will be performed at 1,3,6, and 12 months post-operatively

  • 30 day complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation

  • Delayed Surgical Complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    re-operation, fusion complication, problems with hardware, deformity


Enrollment: 198
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbar Microdiscectomy
Patients aged 18-80 with symptomatic lumbar disc herniation resulting in single nerve root compression recalcitrant to non-invasive therapies for at least 6 weeks
Procedure: Lumbar Discectomy
Microsurgical removal of disc that is compressing a nerve root
Experimental: Single-Level Lumbar Fusion
Patients aged 18-80 with symptomatic grade I degenerative or isthmic spondylolisthesis with mechanical back pain with or without radiculopathy recalcitrant to non-invasive therapies for at least 3 months
Procedure: Single-level lumbar fusion
pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks

Exclusion Criteria:

  • History of previous lumbar spine surgery
  • Significant motor weakness (3/5) (i.e. foot drop)
  • Cancer, infection, or fracture
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220921

Locations
United States, California
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, New Jersey
University of Medicine and Dentistry - New Jersey
Newark, New Jersey, United States, 07103
United States, New York
Columbia University - Neurological Institute
New York, New York, United States, 10032
United States, North Carolina
Carolina Spine
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Canada, Alberta
University of Calgary - Alberta Health Sevices
Calgary, Alberta, Canada, T2N-2T9
Sponsors and Collaborators
Greenwich Hospital
American Association of Neurological Surgeons
Investigators
Study Director: Zoher Ghogawala, MD FACS Yale University
  More Information

Responsible Party: Zoher Ghogawala MD FACS, Wallace Clinical Trials Center - Greenwich Hospital - Yale New Haven Health
ClinicalTrials.gov Identifier: NCT01220921     History of Changes
Other Study ID Numbers: Neuropoint SD 
Study First Received: October 13, 2010
Last Updated: December 3, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Spinal Diseases
Spondylolisthesis
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on May 23, 2016